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VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Peking University People's Hospital
Sponsor:
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01707888
First received: October 13, 2012
Last updated: January 24, 2015
Last verified: January 2015
  Purpose

Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.


Condition Intervention Phase
Non-small Cell Lung Cancer
Procedure: Thoracoscopy/VATS
Phase 3

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • morbidity and mortility rate [ Time Frame: 3 moths ] [ Designated as safety issue: Yes ]
    perioperative complications and death rates of the group


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 3y ] [ Designated as safety issue: No ]
    To evaluate Disease Free Survival (DFS) of the group.

  • Rate of loco-regional and systemic recurrence [ Time Frame: 3y ] [ Designated as safety issue: No ]
    To evaluate the rate of loco-regional and systemic recurrence of the group.

  • Pulmonary function [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    to evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.

  • Postoperative hospital stay. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative hospital stay of the group.

  • Postoperative drainage duration [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative drainage duration of the group.

  • overall survival [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    to evaluate the overall survival rate of the group.

  • converted rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    the rate of converted thoracotomy


Estimated Enrollment: 500
Study Start Date: September 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
major lung resection
Patients undergo major lung resection by thoracoscopy/VATS.
Procedure: Thoracoscopy/VATS
Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.
Other Name: Minimal invasive surgery

Detailed Description:

Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.This is a multicenter, prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung resection for early stage lung cancer. Patients will be followed up every 3 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

clinical early stage(I/II) lung cancer

Criteria

Inclusion Criteria:

Preoperative criteria:

i) non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.

(4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).

(5) No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. (7) Performance status of 0 or 1. (8) Sufficient organ functions. (9) Written informed consent.

Exclusion Criteria:

  1. Active bacterial or fungous infection.
  2. Simultaneous or metachronous (within the past 5 years) double cancers.
  3. Women during pregnancy or breast-feeding.
  4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
  5. Psychosis.
  6. Systemic steroids medication.
  7. Uncontrollable diabetes mellitus.
  8. Uncontrollable hypertension.
  9. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707888

Contacts
Contact: Jun Wang, MD 88324078 Jwangmd@yahoo.com

Locations
China, Beijing
Beijing Anzhen Hospital Not yet recruiting
Beijing, Beijing, China, 100044
Contact: Songlei Ou         
Beijing Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 100044
Contact: Keneng Chen         
Beijing Chao-Yang Hospital Not yet recruiting
Beijing, Beijing, China, 100044
Contact: Hui Li         
Beijing Haidian Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Yuqing Huang         
China
Beijing Friendship Hospital Not yet recruiting
Beijing, China
Contact: Zhi Gao         
Peking university people's hospital Recruiting
Beijing, China
Contact: Jun Wang, MD         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Study Chair: Jun Wang, MD Peking University People's Hospital
Study Director: Fan Yang, MD Peking University People's Hospital
Study Director: Zhao Xi Sui, MD Peking University People's Hospital
  More Information

No publications provided

Responsible Party: Jun Wang, Principal Investigator, Clinical Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01707888     History of Changes
Other Study ID Numbers: PEKUPH1201
Study First Received: October 13, 2012
Last Updated: January 24, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on February 27, 2015